Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
- Determine the maximum tolerated dose of docetaxel when administered with concurrent
boost radiotherapy in patients with advanced squamous cell carcinoma of the head and
neck previously treated with induction chemotherapy.
- Determine the toxicity of this treatment regimen in this patient population.
- Determine the efficacy of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo
hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy
alone twice daily for 2 weeks.
Upon completion of chemoradiotherapy, patients not achieving complete response to induction
chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients
experience dose limiting toxicity. Additional patients are treated at the MTD.
Patients are followed monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Primary Purpose: Treatment
Roy B. Tishler, MD, PhD
Dana-Farber Cancer Institute
United States: Federal Government
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|